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Evaluation of the Healthy Lifestyle Program on Cognitive Outcomes

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03926481
Recruitment Status : Active, not recruiting
First Posted : April 24, 2019
Last Update Posted : September 16, 2020
Sponsor:
Information provided by (Responsible Party):
Robert M. Roth, Dartmouth-Hitchcock Medical Center

Brief Summary:
The goal of this study is to conduct a program of pilot research aimed at evaluating the effect of an intensive lifestyle intervention on cognitive functioning in older adults with obesity and or obesity and sarcopenia.

Condition or disease Intervention/treatment Phase
Obesity Behavioral: Evaluate Healthy Lifestyle Program on cognitive outcomes Not Applicable

Detailed Description:

Detailed Description:

The national epidemic of obesity is also affecting older adults, and is associated with an increased risk of disability, nursing home placement and early mortality. The overarching goal of this study is to conduct a program of pilot research aimed at evaluating the effect of a intensive lifestyle intervention on cognitive functioning in order adults with obesity and or obesity and sarcopenia. While some degree of cognitive decline is common during the normal aging process, epidemiological evidence suggests that obesity can promote its acceleration. It is unclear the effect that intensive lifestyle changes could have on cognitive functioning in older adults with obesity.

Study Timeline:

May 2019 to May 2021

Goal: Conduct a study to evaluate the effects that intensive lifestyle program has on cognitive functioning in older adults with obesity and or obesity and sarcopenia.

Participation Duration: Participants will meet weekly for 17 weeks. Cognitive assessments will take place at baseline and 17 weeks.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation of the Healthy Lifestyle Program on Cognitive Outcomes
Actual Study Start Date : July 10, 2019
Estimated Primary Completion Date : May 2021
Estimated Study Completion Date : May 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Healthy Living

Arm Intervention/treatment
Experimental: Obesity Only
Assess the effect of an intensive lifestyle intervention on cognitive function in adults with obesity who are 65 years and older.
Behavioral: Evaluate Healthy Lifestyle Program on cognitive outcomes
The healthy lifestyle program will be delivered once a week for 17 weeks as part as regular clinical care. It will include an group classes taught by health coaches and dieticians. These classes will focus on diet, exercise, and behavior modification. We plan 2 cohorts of 15 subjects (n=30). In-person research assistant-led assessments will occur at baseline and 17 weeks.

Experimental: Sarcopenia and Obesity
Assess the effect of an intensive lifestyle intervention on cognitive function in adults with obesity and sarcopenia who are 65 years and older.
Behavioral: Evaluate Healthy Lifestyle Program on cognitive outcomes
The healthy lifestyle program will be delivered once a week for 17 weeks as part as regular clinical care. It will include an group classes taught by health coaches and dieticians. These classes will focus on diet, exercise, and behavior modification. We plan 2 cohorts of 15 subjects (n=30). In-person research assistant-led assessments will occur at baseline and 17 weeks.




Primary Outcome Measures :
  1. Change in grip strength [ Time Frame: Baseline and 17 weeks ]
    Assessed by a Jamar dynamometer. Sensor-based Thera-bands will measure data on strength change. A higher score represents a better outcome.

  2. Change in 5 times Sit-to-Stand (STS) [ Time Frame: Baseline and 17 weeks ]
    STS measures lower limb strength (minimal change 2.3 s). A higher score represents a better outcome.

  3. Change in Six-Minute Walk Test (6MWT) [ Time Frame: Baseline and 17 weeks ]
    A surrogate for cardiovascular fitness that measures distance (normal 400-700m) related to function. A clinically important difference is 50-55m

  4. Change in weight in kg [ Time Frame: Baseline and 17 weeks ]
    Change in weight in kg

  5. Change in body mass index (BMI) in kg/m^2 [ Time Frame: Baseline and 17 weeks ]
    Change in body mass index (BMI) in kg/m^2

  6. Change in subject processing speed [ Time Frame: Baseline and 17 weeks ]
    Single Digit Modalities Test: Measure of cognition/processing speed. Score range 0 to 110. A higher score represents a better outcome.

  7. Change in language function [ Time Frame: Baseline and 17 weeks ]
    Boston Naming Test (BNT) is used to evaluate language function. Score range:0-42; higher score indicates better performance.

  8. Change in subject cognition [ Time Frame: Baseline and 17 weeks ]
    Verbal fluency test is used to evaluate language function. Performance will be identified via the total number of appropriate words responded on each of the task. Higher score indicates better performance.

  9. Change in subject executive function [ Time Frame: Baseline and 17 weeks ]
    Stroop test is used to assess executive function. Higher score indicates better performance. Raw score range: 0-300.

  10. Change in speed processing [ Time Frame: Baseline and 17 weeks ]
    Trail making Test-A&B is used to assess information processing speed. Shorter time indicates better performance.

  11. Change in subject memory [ Time Frame: Baseline and 17 weeks ]
    California Verbal Learning Test II (CVLT-II) Trials 1-5 Total raw score (range: 0-80; higher values represent a better outcome)

  12. Change in Brief Visuospatial Memory Test-Revised (BVMT-R) [ Time Frame: Baseline and 17 weeks ]
    BVMT-R is used to evaluate spatial memory ability. Scores range from 0 to 60, with higher values indicating better performance.

  13. Change from baseline Anxiety Symptoms at 17 weeks [ Time Frame: Baseline and 17 weeks ]
    will be assessed using the Generalized Anxiety Disorder-7 (GAD7). The GAD7 scores range from 5-21, with 5-9 indicating mild, 10-14 moderate, and greater than 15 severe anxiety.

  14. Change from baseline Mood Symptoms at 17 weeks [ Time Frame: Baseline and 17 weeks ]
    Will be assessed using the Patient Healthy Questionnaire (PHQ9). The PHQ9 scores range from 0-27, with lower numbers indicating minimal to no depression and higher numbers indicating severe depression.

  15. Change from baseline Subjective Health Status (PROMIS) at 17 weeks [ Time Frame: Baseline and 17 weeks ]
    Patient Reported Outcomes Measurement Information Systems (PROMIS) Global Short Form. PROMIS is a 10-item instrument capturing physical, mental and social aspects of quality of life having undergone quantitative appraisal and is non-proprietary. Higher score indicated more positive perceptions of overall health.

  16. Change in Behavior Rating Inventory of Executive Function (BRIEF-A) [ Time Frame: Baseline and 17 weeks ]
    Behavior Rating Inventory of Executive Function (BREIF-A) is used to evaluate executive functioning.This questionnaire consist of 75 items on which the patient's symptoms are rated on a 3-point Likert scale. The questionnaire provides a Global Executive Composite score (range 75-225) and two index scores: the Behavioral Regulation Index (range 30-90) and the Metacognitive Index (range 40-120) in addition to nine subscales: Inhibit (range 8-24), Shift (range 6-18), Emotional control (range 10-30), Self-monitor (range 6-18), Initiate (range 8-24), Working memory (range 8-24), Plan/organize (range 10-30), Task monitor (range 6-18) and Organization of materials (range 8-24). Higher scores indicate more executive difficulties.

  17. Change in Prospective and Retrospective Memory Questionnaire (PRMQ) [ Time Frame: Baseline and 17 weeks ]
    PRMQ is a questionnaire about daily memory difficulties. Higher scores represent worse outcomes. Total score ranges from 0-64.


Secondary Outcome Measures :
  1. Baseline estimated level of intellectual ability [ Time Frame: Baseline ]
    Test of Premorbid Functioning which results in a total raw score ranging from 0-70, and is normatively scored based on respondents' age resulting in standard scores (mean = 100). Higher values indicate a higher premorbid level of intellect.

  2. Handedness as measured by Edinburgh Handedness Inventory at Baseline [ Time Frame: Baseline ]
    A self report questionnaire assessing the dominance of one's right or left hand in everyday activities.



Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • English Speaking
  • Age ≥65 years
  • Body Composition Body Fat >25% for Men
  • Body Composition Body Fat >30% for Women
  • Participating in the Dartmouth Hitchcock Weight and Wellness Center (WWC) Healthy Lifestyle Program (HLP)
  • Willing and able to give informed consent

Exclusion Criteria:

  • Unable to perform measures
  • Individuals unwilling/unable to provide consent
  • Severe mental or life-threatening illness
  • History of bariatric surgery

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03926481


Locations
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United States, New Hampshire
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03766
Sponsors and Collaborators
Dartmouth-Hitchcock Medical Center
Investigators
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Principal Investigator: Robert M Roth, PhD Dartmouth-Hitchcock Medical Center
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Responsible Party: Robert M. Roth, Associate Professor of Psychiatry, Dartmouth-Hitchcock Medical Center
ClinicalTrials.gov Identifier: NCT03926481    
Other Study ID Numbers: D19091
First Posted: April 24, 2019    Key Record Dates
Last Update Posted: September 16, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Robert M. Roth, Dartmouth-Hitchcock Medical Center:
weight loss
cognition
sarcopenia
obesity
lifestyle
Additional relevant MeSH terms:
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Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight